FDAClass IINovember 19, 2014

Artis zeego systems recall

Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and…

Why was Artis zeego systems recalled?

A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated. Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

model number 10280959, with serial numbers 1000-1599

Product
Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
164
Distribution
Nationwide Distribution including Puerto Rico.
Recall date
November 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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